Mold apparatus and kit for in situ tissue repair

A surgical kit comprising a biomaterial source and a mold apparatus for forming a prosthesis in situ, the apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, wherein the mold apparatus is adapted for use in a method that comprises the steps of:

• a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure,
• wherein the composition parts comprise:
• (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts,
• wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material,
• b) inserting the mold apparatus into a tissue site,
• c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412.
• d) permitting the biomaterial composition to completely cure, and
• e) employing the molded biomaterial in situ as a prosthesis at the tissue site
• wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.